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A Randomized Controlled Trial of Genotype-based Warfarin Initiation in Patients with Mechanical Prosthetic Heart Valve

A Randomized Controlled Trial of Genotype-based Warfarin Initiation in Patients with Mechanical Prosthetic Heart Valve

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12002286
Enrollment
Unknown
Registered
2012-05-29
Start date
2012-06-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cardiac valvular disease

Interventions

1:Genotype-based Warfarin Initiation
2:clinical factor-based warfarin initiation

Sponsors

The first affiliated hospital of Sun Yat Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: All the included patient should be the first time to receive the mitral and/or aortic mechanical prosthetic valve repalcement. They should be willing to join in the clinical trial and comply with the protocol.

Exclusion criteria

Exclusion criteria: All the patients with the following criteria should be excluded:other ethics than Han; previously receive any other cardiac surgery; emergent surgery;simutaneously carry out other cardiac surgeries; age younger than 18y or older than 65y; drug abuser and wine abuser; any malignancy;any chronic hepatic or kidney disease; any thyroid disease; the history of warfarin or VitK consumption 2 week before the surgery; any hematological disease or history of bleeding; combination with any drugs that significantly influence warfarin other than Cordarone; pregnancy; any contraindication of warfarin; infectious endocarditis; advanced valvular disease; pathological obesity;psychological disease; any patient having joined in other clinical trial in the previous 30d; basic INR>1.4.

Design outcomes

Primary

MeasureTime frame
time to steady dosage;Time in Therapeutic Range;

Secondary

MeasureTime frame
first time to treatment window;the ratio of INR>=3.0 and INR<=1.5;the monitoring frequency of INR;the whole-cause mortality large bleeding event and large thrombosis rate;

Contacts

Public ContactZhang Xi
zhangxisysu@163.com+86 13902279690

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026